Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
The investigators hypothesize that graft rejection after hematopoietic stem cell transplant (HSCT) is primarily driven by interferon gamma, and prophylactic interferon gamma inhibition in high-risk patients will prevent graft rejection. Additionally, knowledge of emapalumab PK/PD and in vitro mechanistic effects of emapalumab in this novel setting will guide optimization of dosing regimens and treatment approaches in future studies.
Eligibility criteria
Qualifiers
All patients undergoing allogeneic HSCT at our institution will be evaluated for graft rejection risk factors. Patients deemed high risk for graft rejection will have 2 or more of the following: mismatched or haploidentical donor, ex vivo t-cell depleted graft, prior history of graft rejection.
Disqualifiers
Known hypersensitivity to any constituent of the study medication.
Trial design
Treatments tested in this trial
- Emapalumab 3 mg/kg
- Emapalumab 10 mg/kg
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Sobi, Inc.
Collaborator
Source ClinicalTrials.gov